Bruce Gordon has been a scientific evaluator with the Marketed Health Products Directorate (MHPD) at Health Canada since 2001. He has a background in molecular biology, and significant experience in the post-market safety review of biologic products, including recombinant biotherapeutics and blood products. Over the past 19 years, he has led multiple high-profile safety reviews that resulted in regulatory actions as well as numerous risk communications. More recently, he has had important policy and process development roles in the MHPD, including leading the development and implementation of a new signal detection working group to evaluate all company-submitted Periodic Benefit-Risk Evaluation Reports (PBRERs) for biologics.

Laura Johnson received her Honour's Bachelor degree in Chemistry from the University of Ottawa. She joined Health Canada in 1995 as an officer responding to Access to Information requests, then held several positions related to submission management. Since 2003 Laura has been involved with the development and implementation of the Summary Basis of Decision (SBD) project. She currently manages the operational implementation of pre-market transparency initiatives and supervises the SBD technical writers in the Therapeutic Products Directorate, Health Canada.

Keith McIntosh is Executive Director, Scientific & Regulatory Affairs at Innovative Medicines Canada, and joined the organization in 2012. Previously, Keith spent 12 years in progressively senior policy and regulatory roles at another trade association. He has successfully advocated industry positions to federal, provincial and municipal departments and agencies covering a diversity of issues and topics. Keith has primary responsibility for the association’s interactions with Health Canada’s drug review bureaus, and developing the association’s positions on regulatory proposals and amendments. He also supports the work of the Regulatory Affairs and PMPRB committees, among others.

Kelly joined Health Canada in 2001 and has experience in both the pre-market and post-market regulation of biologics and pharmaceuticals. Kelly has been involved in initiatives such as international work sharing under Access and Project Orbis, HTA alignment and policy related to submissions relying on third party data. Kelly rejoined the Marketed Health Products Directorate as the Director General in 2020, where she leads a diverse team responsible for post-market activities including RWE, Advertising, Risk Management and Health Product Vigilance.

Matthew Ryan is currently a Senior Policy Analyst in the Strategic Horizontal Policy Division within the Policy, Planning and International Affairs Directorate (PPIAD) at the Health Products and Food Branch (HPFB). He recently held the position of Senior Advisor in the both the Assistant Deputy Minister’s Office and the Director General's Office of the Therapeutic Products Directorate. In addition, during his over ten years with Health Canada, he has held project management and policy positions in the Bureau of Cardiology, Allergy and Neurological Sciences, the Bureau of Pharmaceutical Sciences and the International Affairs Directorate within the Strategic Policy Branch (SPB).

Kristin Willemsen is the Vice President of Scientific and Regulatory Affairs at Food, Health & Consumer Products Canada. Since 2008, she has been working with members to influence the regulation, policy and administration of over-the-counter drugs and natural health products. Kristin earned a Masters of Science from the University of Ottawa and is a Certified Association Executive.

Matthew has been working at Health Canada for the last 15 years. During this time he has specialized in the areas of compliance and enforcement of natural health products, quality requirements for active pharmaceutical ingredients, risk management and the development of regulatory reform for non-prescription drugs and natural health products. Presently, Matthew Bown is the policy lead for the development of the Self-Care Framework and its three phases. Along with a small team at NNHPD, Matthew is responsible for the development of Departmental positions on a variety of issues, including the oversight of the development of regulatory proposals.

Andrew Casey became president and CEO of BIOTECanada in August, 2012. In his role as President & CEO of BIOTECanada Andrew is responsible for the strategic operations of the Association representing Canada’s biotechnology sector. As the head of BIOTECanada, he is the lead spokesperson for Canada's biotechnology industry communicating on the industry's behalf with government, regulators, international bodies, media and the Canadian public.

Karen Feltmate is the President of Redstone Health Group Inc., a consulting firm providing regulatory strategy and guidance to the innovative Pharmaceutical industry. Karen has over 20 years of corporate executive experience primarily in the area of Canadian Federal registration and also manufacturing, packaging, quality and distribution. Karen holds a B.Sc. in Biology from McMaster University. She is a past Board member of both the Canadian Pharmaceutical Distribution Network (CPDN) and the University of Toronto Biotechnology Bridging Program. She is a member of the Drug Information Association, and was a founding member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA).

Celia Lourenco, PhD has been the Director General of the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) of the Health Products and Food Branch of Health Canada since November 2018. She was previously the Senior Executive Director of the Therapeutic Products Directorate (TPD) and held other management positions within TPD over a period of about 10 years. In her various management roles, Celia has been responsible for the review and authorization of a variety of new drugs for human use, either for clinical trials or for market authorization in Canada. Celia has contributed to international initiatives such as ICH and IPRP, she co-chairs the ICMRA COVID-19 working group and participates on DIA's Council of Regulators.

Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degree in Genomics & Computer Science from McGill University.

Eva Miller is Senior Director, Biostatistics, at inVentiv Health. Eva works with sponsors to design and implement adaptive clinical trials in over 30 therapeutic areas.. Eva received her Ph.D. at the U of P and is a member of DIA, DIA Statistics SIAC, ASA, and Adaptive Designs Working Group.

Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document and submission management.

Anne has practiced exclusively in the area of Regulatory Affairs in Canada since 1971. She has worked for three pharmaceutical companies: Wyeth, Roche and Searle. She started the regulatory consulting company, CanReg Inc, that was later sold to a US company. After working with the purchaser for 4 years, Anne set up her current regulatory consulting company, Therapeutic Products Inc. (TPIreg), which provides regulatory consulting in Canada and the US, including eCTD publishing. TPIreg also provides QA services in Canada and the US and holds and Establishment Licence with Health Canada as an importer. Anne operates out of Hamilton, Ontario.

Sandra is currently the Associate VP Regulatory Affairs, Quality and Safety for Eli Lilly Canada Inc., an importer and distributor of pharmaceuticals and Medical Device Products as well as clinical trial sponsor , where she has oversight and responsibility for all regulatory, quality and pharmacovigilance activities. Sandra has over 24 plus years experience in the industry and holds a Bachelor of Science degree from the University of Guelph

Tharany Ganesh has been with AstraZeneca since 2006, holding progressive roles in Regulatory Affairs, Quality Assurance and Patient Safety. She has worked in several different therapy areas including Oncology, Cardiovascular, Respiratory, Vaccines and Infectious Diseases, Gastrointestinal and Neuroscience during her career at AstraZeneca and is the current Head of Regulatory Affairs for the Canadian business. Tharany holds a Master of Biotechnology degree from the University of Toronto, and an Honours Bachelor of Science degree from the University of Waterloo.

Yannis is an experienced statistician. Over the course of 15 years, Yannis has led the development of Cytel’s software and strategic consulting offerings. In his current role as CSO, Yannis has oversight of the corporate-level scientific agenda. This includes research portfolios in complex and innovative clinical trial designs, Bayesian methods, platform trials and master protocols, and advanced uses of real-world evidence to strengthen regulatory submissions. Yannis research interests include causal inference, adaptive trial design, financial and clinical strategy, statistical computing and regulatory affairs.